NCT05313035已完成2 期
A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma) Adjuvanted With Alum+CpG 1018 in Healthy Populations Aged 18 Years and Above in Indonesia
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- PT Bio Farma
- 入组人数
- 360
- 试验地点
- 3
- 主要终点
- Immunogenicity of the candidate vaccine
研究概览
简要总结
This trial is observer-blind, comparative, randomized, placebo-controlled phase 2 study. The population is healthy subjects aged 18 and above
详细描述
The phase 2 is dose-ranging study which will recruit 360 subjects to compare two vaccine formulas to placebo (1:1:1), to evaluate the safety and immunogenicity of the vaccine. The subjects will be given 2 doses of investigational product with 28 days interval between doses.
One selected vaccine formula will be evaluated for safety and persistence antibody until 6 months after the last dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Vaccine candidate and placebo are masking, lot number is masking
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinically healthy subjects aged 18 years and above.
- •Subjects have been informed properly regarding the study and signed the informed consent form.
- •Subjects will commit to comply with the instructions of the investigator and the schedule of the trial.
排除标准
- •Subjects concomitantly enrolled or scheduled to be enrolled in another trial.
- •History of vaccination with any COVID-19 vaccine.
- •History of COVID-19 within 1 month (for mild-moderate disease) or 3 months (for severe disease) prior to enrollment.
- •Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun).
- •Women who are pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results).
- •History of uncontrolled asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema.
- •History of blood disorders contraindicating intramuscular injection.
- •Patients with serious chronic diseases (serious cardiovascular diseases, uncontrolled hypertension and diabetes, liver and kidney diseases, malignant tumors, etc) which according to the investigator might interfere with the assessment of the trial objectives.
- •History of confirmed or suspected immunosuppressive or immunodeficient state, or received in the previous 4 weeks a treatment likely to alter the immuneresponse (intravenous immunoglobulins, blood-derived products or long-term corticosteroid therapy (> 2 weeks)).
- •History of uncontrolled epilepsy or other progressive neurological disorders, such as Guillain-Barre syndrome.
- •Subjects receive any vaccination (other than COVID-19 vaccine) within 1 month before and after IP immunization.
- •Subjects plan to move from the study area before the end of study period.
结局指标
主要结局
Immunogenicity of the candidate vaccine
时间窗: 14 days after the last dose
seroconversion rate of antibody (IgG and neutralization antibody)
次要结局
- Safety of the candidate vaccine(28 days after each dose)
- Serious Adverse Event (SAE) of the vaccine(6 months after the last dose)
- Persistence antibody of vaccine candidate(14 days, 28 days, 3 months, 6 months after the last dose)
研究者
研究点 (3)
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